BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE

    K Number: K900903 · Decision May 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    236
    Registration Numbers
    236
    Same Product Code
    27
    Applicant Total
    8
    Review Days
    65

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    Basic Information

    Device Name
    KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE
    K Number
    K900903
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Milex Products, Inc.
    Date Received
    February 27, 1990
    Decision Date
    May 3, 1990
    Product Code
    GDF
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GDF Guide, Needle, Surgical

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